Oral Motor Intervention for Preterm Babies

NCT ID: NCT06046157

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-01-31

Brief Summary

The goal of this clinical trial is to evaluate the effect of oral motor intervention (PIOMI) applied to preterm babies along with the smell and taste of breast milk on feeding parameters and the transition time to oral feeding. The main questions it aims to answer are:

• Does affect nutritional parameters PIOMI with the smell of breast milk?
• Does affect nutritional parameters PIOMI with breast milk taste? Participants will consist of breast milk-scented PIOMI, breast milk-tasting PIOMI and control groups.

Researchers will compare breast milk-scented PIOMI, breast milk-tasting PIOMI and control groups to see if early feeding skills.

Detailed Description

The preterm newborn population is potentially unable to be fed orally for a long time during the postnatal period. Since the physiological functions of preterm babies have not yet matured, their adaptation to the external uterine environment is more complicated. This also means long hospital stays for premature babies. One of the main criteria for a preterm baby to be discharged from the hospital is to be able to feed orally.

Premature oral motor intervention (PIOMI) is included in the literature as one of the treatment programs to improve the oral motor control and neurobehavioral status of preterm babies. No study design has been found regarding PIOMI, which is applied to preterm babies with the smell and taste of breast milk. This research was planned to evaluate the effect of oral motor intervention (PIOMI) applied to preterm babies along with the smell and taste of breast milk on feeding parameters.

Conditions

Preterm Babies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Breast milk-scented PIOMI

During PIOMI application, the baby will be smelled his/her own breast milk.

Group Type: EXPERIMENTAL

Breast milk-scented PIOMI

Intervention Type: OTHER

During PIOMI, the scent of breast milk will be provided through cotton soaked in breast milk placed 1.5 cm away from the babies.

PIOMI: Oral motor intervention for premature infants is a standardized oral motor therapy for preterm infants that has been shown to have strong intervention fidelity and has been tested internationally.

It is a 5-minute, 8-step focused therapy designed to help the premature baby respond functionally to lip, chin and lip movements and pressure, applied for 7 consecutive days using all aseptic precautions with gloved fingers.

Intervention provides assisted movement to activate muscle contraction and movement against resistance to build strength.

Breast milk-tasting PIOMI

During PIOMI application, the baby will be able to taste his own breast milk. The finger on which PIOMI was applied will be immersed in breast milk.

Group Type: EXPERIMENTAL

Breast milk-tasting PIOMI

Intervention Type: OTHER

The finger used during PIOMI application will be performed by dipping it into breast milk. This will ensure that babies taste breast milk.

PIOMI: Oral motor intervention for premature infants is a standardized oral motor therapy for preterm infants that has been shown to have strong intervention fidelity and has been tested internationally.

It is a 5-minute, 8-step focused therapy designed to help the premature baby respond functionally to lip, chin and lip movements and pressure, applied for 7 consecutive days using all aseptic precautions with gloved fingers.

Intervention provides assisted movement to activate muscle contraction and movement against resistance to build strength.

Control

Only PIOMI application will be made.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Breast milk-scented PIOMI

During PIOMI, the scent of breast milk will be provided through cotton soaked in breast milk placed 1.5 cm away from the babies.

PIOMI: Oral motor intervention for premature infants is a standardized oral motor therapy for preterm infants that has been shown to have strong intervention fidelity and has been tested internationally.

It is a 5-minute, 8-step focused therapy designed to help the premature baby respond functionally to lip, chin and lip movements and pressure, applied for 7 consecutive days using all aseptic precautions with gloved fingers.

Intervention provides assisted movement to activate muscle contraction and movement against resistance to build strength.

Intervention Type: OTHER

Breast milk-tasting PIOMI

The finger used during PIOMI application will be performed by dipping it into breast milk. This will ensure that babies taste breast milk.

PIOMI: Oral motor intervention for premature infants is a standardized oral motor therapy for preterm infants that has been shown to have strong intervention fidelity and has been tested internationally.

It is a 5-minute, 8-step focused therapy designed to help the premature baby respond functionally to lip, chin and lip movements and pressure, applied for 7 consecutive days using all aseptic precautions with gloved fingers.

Intervention provides assisted movement to activate muscle contraction and movement against resistance to build strength.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Breastfed,
• Preterm babies with a gestational age of 28-32 weeks,
• No facial deformity,
• No respiratory, cardiovascular, gastrointestinal or neurological disorders or syndromes that would prevent or complicate oral feeding,
• It will produce preterm babies who are not fed orally but are fed via tube (orogastric).

Exclusion Criteria

• Having respiratory distress,
• Babies who do not receive informed consent form from the parents will not be included.

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MSc İlknur Budancamanak

UNKNOWN

Sponsor Role: collaborator

Professor Kadir Şerafettin Tekgündüz

UNKNOWN

Sponsor Role: collaborator

Associate Professor Mustafa Kara

UNKNOWN

Sponsor Role: collaborator

MSc Ebru Betül Albayrak

UNKNOWN

Sponsor Role: collaborator

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Türkan Kadiroğlu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ataturk University

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

B. 30.2. ATA.0.01.00/702

Identifier Type: -

Identifier Source: org_study_id